Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)
Identifieur interne : 003D99 ( Ncbi/Merge ); précédent : 003D98; suivant : 003E00Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)
Auteurs : Josef S. Smolen [Autriche] ; Joel M. Kremer [États-Unis] ; Carol L. Gaich [États-Unis] ; Amy M. Delozier [États-Unis] ; Douglas E. Schlichting [États-Unis] ; Li Xie [États-Unis] ; Ivaylo Stoykov [États-Unis] ; Terence Rooney [États-Unis] ; Paul Bird [Australie] ; Juan Miguel Sánchez Burs N [Espagne] ; Mark C. Genovese [États-Unis] ; Bernard Combe [France]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Azétidines (usage thérapeutique), Enquêtes et questionnaires, Humains, Indice de gravité médicale, Inhibiteurs de protéines kinases (usage thérapeutique), Jeune adulte, Mesure de la douleur, Mesures des résultats rapportés par les patients, Méthode en double aveugle, Polyarthrite rhumatoïde (), Polyarthrite rhumatoïde (traitement médicamenteux), Présentéisme, Qualité de vie, Rendement, Sulfonamides (usage thérapeutique).
- MESH :
- traitement médicamenteux : Polyarthrite rhumatoïde.
- usage thérapeutique : Azétidines, Inhibiteurs de protéines kinases, Sulfonamides.
- Adulte, Enquêtes et questionnaires, Humains, Indice de gravité médicale, Jeune adulte, Mesure de la douleur, Mesures des résultats rapportés par les patients, Méthode en double aveugle, Polyarthrite rhumatoïde, Présentéisme, Qualité de vie, Rendement.
English descriptors
- KwdEn :
- Adult, Arthritis, Rheumatoid (complications), Arthritis, Rheumatoid (drug therapy), Azetidines (therapeutic use), Double-Blind Method, Efficiency, Humans, Pain Measurement, Patient Reported Outcome Measures, Presenteeism, Protein Kinase Inhibitors (therapeutic use), Quality of Life, Severity of Illness Index, Sulfonamides (therapeutic use), Surveys and Questionnaires, Young Adult.
- MESH :
- chemical , therapeutic use : Azetidines, Protein Kinase Inhibitors, Sulfonamides.
- complications : Arthritis, Rheumatoid.
- drug therapy : Arthritis, Rheumatoid.
- Adult, Double-Blind Method, Efficiency, Humans, Pain Measurement, Patient Reported Outcome Measures, Presenteeism, Quality of Life, Severity of Illness Index, Surveys and Questionnaires, Young Adult.
Abstract
To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).
In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form-36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.
527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI <0.5; p≤0.001), reductions in fatigue (FACIT-F ≥3.56; p≤0.05), improvements in PtGA (p≤0.001) and pain (p≤0.001) and reductions in duration of MJS (p<0.01).
Baricitinib improved most PROs through 24 weeks compared with placebo in this study of treatment-refractory patients with previously inadequate responses to bDMARDs, including at least one TNFi. PRO results aligned with clinical efficacy data for baricitinib.
Url:
DOI: 10.1136/annrheumdis-2016-209821
PubMed: 27799159
PubMed Central: 5530360
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)</title>
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<author><name sortKey="Xie, Li" sort="Xie, Li" uniqKey="Xie L" first="Li" last="Xie">Li Xie</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Stoykov, Ivaylo" sort="Stoykov, Ivaylo" uniqKey="Stoykov I" first="Ivaylo" last="Stoykov">Ivaylo Stoykov</name>
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,<country>USA</country>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Rooney, Terence" sort="Rooney, Terence" uniqKey="Rooney T" first="Terence" last="Rooney">Terence Rooney</name>
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,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Bird, Paul" sort="Bird, Paul" uniqKey="Bird P" first="Paul" last="Bird">Paul Bird</name>
<affiliation wicri:level="1"><nlm:aff id="af4"><institution>University of New South Wales</institution>
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</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Sanchez Burs N, Juan Miguel" sort="Sanchez Burs N, Juan Miguel" uniqKey="Sanchez Burs N J" first="Juan Miguel" last="Sánchez Burs N">Juan Miguel Sánchez Burs N</name>
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,<addr-line>Sevilla</addr-line>
,<country>Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<author><name sortKey="Genovese, Mark C" sort="Genovese, Mark C" uniqKey="Genovese M" first="Mark C" last="Genovese">Mark C. Genovese</name>
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,<addr-line>Palo Alto, California</addr-line>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
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</nlm:aff>
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<series><title level="j">Annals of the Rheumatic Diseases</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Arthritis, Rheumatoid (complications)</term>
<term>Arthritis, Rheumatoid (drug therapy)</term>
<term>Azetidines (therapeutic use)</term>
<term>Double-Blind Method</term>
<term>Efficiency</term>
<term>Humans</term>
<term>Pain Measurement</term>
<term>Patient Reported Outcome Measures</term>
<term>Presenteeism</term>
<term>Protein Kinase Inhibitors (therapeutic use)</term>
<term>Quality of Life</term>
<term>Severity of Illness Index</term>
<term>Sulfonamides (therapeutic use)</term>
<term>Surveys and Questionnaires</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term>
<term>Azétidines (usage thérapeutique)</term>
<term>Enquêtes et questionnaires</term>
<term>Humains</term>
<term>Indice de gravité médicale</term>
<term>Inhibiteurs de protéines kinases (usage thérapeutique)</term>
<term>Jeune adulte</term>
<term>Mesure de la douleur</term>
<term>Mesures des résultats rapportés par les patients</term>
<term>Méthode en double aveugle</term>
<term>Polyarthrite rhumatoïde ()</term>
<term>Polyarthrite rhumatoïde (traitement médicamenteux)</term>
<term>Présentéisme</term>
<term>Qualité de vie</term>
<term>Rendement</term>
<term>Sulfonamides (usage thérapeutique)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Azetidines</term>
<term>Protein Kinase Inhibitors</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Arthritis, Rheumatoid</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Arthritis, Rheumatoid</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Polyarthrite rhumatoïde</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Azétidines</term>
<term>Inhibiteurs de protéines kinases</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Double-Blind Method</term>
<term>Efficiency</term>
<term>Humans</term>
<term>Pain Measurement</term>
<term>Patient Reported Outcome Measures</term>
<term>Presenteeism</term>
<term>Quality of Life</term>
<term>Severity of Illness Index</term>
<term>Surveys and Questionnaires</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Enquêtes et questionnaires</term>
<term>Humains</term>
<term>Indice de gravité médicale</term>
<term>Jeune adulte</term>
<term>Mesure de la douleur</term>
<term>Mesures des résultats rapportés par les patients</term>
<term>Méthode en double aveugle</term>
<term>Polyarthrite rhumatoïde</term>
<term>Présentéisme</term>
<term>Qualité de vie</term>
<term>Rendement</term>
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<front><div type="abstract" xml:lang="en"><sec><title>Objectives</title>
<p>To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).</p>
</sec>
<sec><title>Methods</title>
<p>In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form-36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.</p>
</sec>
<sec><title>Results</title>
<p>527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI <0.5; p≤0.001), reductions in fatigue (FACIT-F ≥3.56; p≤0.05), improvements in PtGA (p≤0.001) and pain (p≤0.001) and reductions in duration of MJS (p<0.01).</p>
</sec>
<sec><title>Conclusions</title>
<p>Baricitinib improved most PROs through 24 weeks compared with placebo in this study of treatment-refractory patients with previously inadequate responses to bDMARDs, including at least one TNFi. PRO results aligned with clinical efficacy data for baricitinib.</p>
</sec>
<sec><title>Trial registration number</title>
<p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01721044">NCT01721044</ext-link>
; Results.</p>
</sec>
</div>
</front>
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</TEI>
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<author><name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S" last="Smolen">Josef S. Smolen</name>
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,<addr-line>Vienna</addr-line>
,<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Kremer, Joel M" sort="Kremer, Joel M" uniqKey="Kremer J" first="Joel M" last="Kremer">Joel M. Kremer</name>
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,<addr-line>Albany, New York</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Gaich, Carol L" sort="Gaich, Carol L" uniqKey="Gaich C" first="Carol L" last="Gaich">Carol L. Gaich</name>
<affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>
,<addr-line>Indianapolis, Indiana</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Delozier, Amy M" sort="Delozier, Amy M" uniqKey="Delozier A" first="Amy M" last="Delozier">Amy M. Delozier</name>
<affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>
,<addr-line>Indianapolis, Indiana</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Schlichting, Douglas E" sort="Schlichting, Douglas E" uniqKey="Schlichting D" first="Douglas E" last="Schlichting">Douglas E. Schlichting</name>
<affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>
,<addr-line>Indianapolis, Indiana</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Xie, Li" sort="Xie, Li" uniqKey="Xie L" first="Li" last="Xie">Li Xie</name>
<affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>
,<addr-line>Indianapolis, Indiana</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Stoykov, Ivaylo" sort="Stoykov, Ivaylo" uniqKey="Stoykov I" first="Ivaylo" last="Stoykov">Ivaylo Stoykov</name>
<affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>
,<addr-line>Indianapolis, Indiana</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Rooney, Terence" sort="Rooney, Terence" uniqKey="Rooney T" first="Terence" last="Rooney">Terence Rooney</name>
<affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>
,<addr-line>Indianapolis, Indiana</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Bird, Paul" sort="Bird, Paul" uniqKey="Bird P" first="Paul" last="Bird">Paul Bird</name>
<affiliation wicri:level="1"><nlm:aff id="af4"><institution>University of New South Wales</institution>
,<addr-line>Sydney, New South Wales</addr-line>
,<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Sanchez Burs N, Juan Miguel" sort="Sanchez Burs N, Juan Miguel" uniqKey="Sanchez Burs N J" first="Juan Miguel" last="Sánchez Burs N">Juan Miguel Sánchez Burs N</name>
<affiliation wicri:level="1"><nlm:aff id="af5"><addr-line>Divisions of Rheumatology, Ophthalmology and Immunology</addr-line>
,<institution>Valme University Hospital</institution>
,<addr-line>Sevilla</addr-line>
,<country>Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Genovese, Mark C" sort="Genovese, Mark C" uniqKey="Genovese M" first="Mark C" last="Genovese">Mark C. Genovese</name>
<affiliation wicri:level="1"><nlm:aff id="af6"><institution>Stanford University Medical Center</institution>
,<addr-line>Palo Alto, California</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
<affiliation wicri:level="1"><nlm:aff id="af7"><institution>Lapeyronie Hospital, Montpellier University</institution>
,<addr-line>Montpellier</addr-line>
,<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">27799159</idno>
<idno type="pmc">5530360</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5530360</idno>
<idno type="RBID">PMC:5530360</idno>
<idno type="doi">10.1136/annrheumdis-2016-209821</idno>
<date when="2016">2016</date>
<idno type="wicri:Area/Pmc/Corpus">002258</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002258</idno>
<idno type="wicri:Area/Pmc/Curation">002108</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002108</idno>
<idno type="wicri:Area/Pmc/Checkpoint">000718</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000718</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)</title>
<author><name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S" last="Smolen">Josef S. Smolen</name>
<affiliation wicri:level="1"><nlm:aff id="af1"><institution>Medical University of Vienna and Hietzing Hospital</institution>
,<addr-line>Vienna</addr-line>
,<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Kremer, Joel M" sort="Kremer, Joel M" uniqKey="Kremer J" first="Joel M" last="Kremer">Joel M. Kremer</name>
<affiliation wicri:level="1"><nlm:aff id="af2"><institution>Albany Medical College</institution>
,<addr-line>Albany, New York</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Gaich, Carol L" sort="Gaich, Carol L" uniqKey="Gaich C" first="Carol L" last="Gaich">Carol L. Gaich</name>
<affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>
,<addr-line>Indianapolis, Indiana</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Delozier, Amy M" sort="Delozier, Amy M" uniqKey="Delozier A" first="Amy M" last="Delozier">Amy M. Delozier</name>
<affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>
,<addr-line>Indianapolis, Indiana</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Schlichting, Douglas E" sort="Schlichting, Douglas E" uniqKey="Schlichting D" first="Douglas E" last="Schlichting">Douglas E. Schlichting</name>
<affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>
,<addr-line>Indianapolis, Indiana</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Xie, Li" sort="Xie, Li" uniqKey="Xie L" first="Li" last="Xie">Li Xie</name>
<affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>
,<addr-line>Indianapolis, Indiana</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Stoykov, Ivaylo" sort="Stoykov, Ivaylo" uniqKey="Stoykov I" first="Ivaylo" last="Stoykov">Ivaylo Stoykov</name>
<affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>
,<addr-line>Indianapolis, Indiana</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Rooney, Terence" sort="Rooney, Terence" uniqKey="Rooney T" first="Terence" last="Rooney">Terence Rooney</name>
<affiliation wicri:level="1"><nlm:aff id="af3"><institution>Eli Lilly and Company</institution>
,<addr-line>Indianapolis, Indiana</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Bird, Paul" sort="Bird, Paul" uniqKey="Bird P" first="Paul" last="Bird">Paul Bird</name>
<affiliation wicri:level="1"><nlm:aff id="af4"><institution>University of New South Wales</institution>
,<addr-line>Sydney, New South Wales</addr-line>
,<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Sanchez Burs N, Juan Miguel" sort="Sanchez Burs N, Juan Miguel" uniqKey="Sanchez Burs N J" first="Juan Miguel" last="Sánchez Burs N">Juan Miguel Sánchez Burs N</name>
<affiliation wicri:level="1"><nlm:aff id="af5"><addr-line>Divisions of Rheumatology, Ophthalmology and Immunology</addr-line>
,<institution>Valme University Hospital</institution>
,<addr-line>Sevilla</addr-line>
,<country>Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Genovese, Mark C" sort="Genovese, Mark C" uniqKey="Genovese M" first="Mark C" last="Genovese">Mark C. Genovese</name>
<affiliation wicri:level="1"><nlm:aff id="af6"><institution>Stanford University Medical Center</institution>
,<addr-line>Palo Alto, California</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
<affiliation wicri:level="1"><nlm:aff id="af7"><institution>Lapeyronie Hospital, Montpellier University</institution>
,<addr-line>Montpellier</addr-line>
,<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series><title level="j">Annals of the Rheumatic Diseases</title>
<idno type="ISSN">0003-4967</idno>
<idno type="eISSN">1468-2060</idno>
<imprint><date when="2016">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Objectives</title>
<p>To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).</p>
</sec>
<sec><title>Methods</title>
<p>In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form-36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.</p>
</sec>
<sec><title>Results</title>
<p>527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI <0.5; p≤0.001), reductions in fatigue (FACIT-F ≥3.56; p≤0.05), improvements in PtGA (p≤0.001) and pain (p≤0.001) and reductions in duration of MJS (p<0.01).</p>
</sec>
<sec><title>Conclusions</title>
<p>Baricitinib improved most PROs through 24 weeks compared with placebo in this study of treatment-refractory patients with previously inadequate responses to bDMARDs, including at least one TNFi. PRO results aligned with clinical efficacy data for baricitinib.</p>
</sec>
<sec><title>Trial registration number</title>
<p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01721044">NCT01721044</ext-link>
; Results.</p>
</sec>
</div>
</front>
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</div1>
</back>
</TEI>
</pmc>
<pubmed><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON).</title>
<author><name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S" last="Smolen">Josef S. Smolen</name>
<affiliation wicri:level="3"><nlm:affiliation>Medical University of Vienna and Hietzing Hospital, Vienna, Austria.</nlm:affiliation>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Medical University of Vienna and Hietzing Hospital, Vienna</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kremer, Joel M" sort="Kremer, Joel M" uniqKey="Kremer J" first="Joel M" last="Kremer">Joel M. Kremer</name>
<affiliation wicri:level="2"><nlm:affiliation>Albany Medical College, Albany, New York, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Albany Medical College, Albany, New York</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Gaich, Carol L" sort="Gaich, Carol L" uniqKey="Gaich C" first="Carol L" last="Gaich">Carol L. Gaich</name>
<affiliation wicri:level="2"><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea>
<placeName><region type="state">Indiana</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Delozier, Amy M" sort="Delozier, Amy M" uniqKey="Delozier A" first="Amy M" last="Delozier">Amy M. Delozier</name>
<affiliation wicri:level="2"><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea>
<placeName><region type="state">Indiana</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schlichting, Douglas E" sort="Schlichting, Douglas E" uniqKey="Schlichting D" first="Douglas E" last="Schlichting">Douglas E. Schlichting</name>
<affiliation wicri:level="2"><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea>
<placeName><region type="state">Indiana</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Xie, Li" sort="Xie, Li" uniqKey="Xie L" first="Li" last="Xie">Li Xie</name>
<affiliation wicri:level="2"><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea>
<placeName><region type="state">Indiana</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Stoykov, Ivaylo" sort="Stoykov, Ivaylo" uniqKey="Stoykov I" first="Ivaylo" last="Stoykov">Ivaylo Stoykov</name>
<affiliation wicri:level="2"><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea>
<placeName><region type="state">Indiana</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Rooney, Terence" sort="Rooney, Terence" uniqKey="Rooney T" first="Terence" last="Rooney">Terence Rooney</name>
<affiliation wicri:level="2"><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea>
<placeName><region type="state">Indiana</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bird, Paul" sort="Bird, Paul" uniqKey="Bird P" first="Paul" last="Bird">Paul Bird</name>
<affiliation wicri:level="1"><nlm:affiliation>University of New South Wales, Sydney, New South Wales, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>University of New South Wales, Sydney, New South Wales</wicri:regionArea>
<wicri:noRegion>New South Wales</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sanchez Burs N, Juan Miguel" sort="Sanchez Burs N, Juan Miguel" uniqKey="Sanchez Burs N J" first="Juan Miguel" last="Sánchez Burs N">Juan Miguel Sánchez Burs N</name>
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<author><name sortKey="Genovese, Mark C" sort="Genovese, Mark C" uniqKey="Genovese M" first="Mark C" last="Genovese">Mark C. Genovese</name>
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<author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON).</title>
<author><name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S" last="Smolen">Josef S. Smolen</name>
<affiliation wicri:level="3"><nlm:affiliation>Medical University of Vienna and Hietzing Hospital, Vienna, Austria.</nlm:affiliation>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Medical University of Vienna and Hietzing Hospital, Vienna</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kremer, Joel M" sort="Kremer, Joel M" uniqKey="Kremer J" first="Joel M" last="Kremer">Joel M. Kremer</name>
<affiliation wicri:level="2"><nlm:affiliation>Albany Medical College, Albany, New York, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Albany Medical College, Albany, New York</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Gaich, Carol L" sort="Gaich, Carol L" uniqKey="Gaich C" first="Carol L" last="Gaich">Carol L. Gaich</name>
<affiliation wicri:level="2"><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea>
<placeName><region type="state">Indiana</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Delozier, Amy M" sort="Delozier, Amy M" uniqKey="Delozier A" first="Amy M" last="Delozier">Amy M. Delozier</name>
<affiliation wicri:level="2"><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea>
<placeName><region type="state">Indiana</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schlichting, Douglas E" sort="Schlichting, Douglas E" uniqKey="Schlichting D" first="Douglas E" last="Schlichting">Douglas E. Schlichting</name>
<affiliation wicri:level="2"><nlm:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea>
<placeName><region type="state">Indiana</region>
</placeName>
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</author>
<author><name sortKey="Xie, Li" sort="Xie, Li" uniqKey="Xie L" first="Li" last="Xie">Li Xie</name>
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<placeName><region type="state">Indiana</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Stoykov, Ivaylo" sort="Stoykov, Ivaylo" uniqKey="Stoykov I" first="Ivaylo" last="Stoykov">Ivaylo Stoykov</name>
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<placeName><region type="state">Indiana</region>
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</author>
<author><name sortKey="Rooney, Terence" sort="Rooney, Terence" uniqKey="Rooney T" first="Terence" last="Rooney">Terence Rooney</name>
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<wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea>
<placeName><region type="state">Indiana</region>
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</author>
<author><name sortKey="Bird, Paul" sort="Bird, Paul" uniqKey="Bird P" first="Paul" last="Bird">Paul Bird</name>
<affiliation wicri:level="1"><nlm:affiliation>University of New South Wales, Sydney, New South Wales, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>University of New South Wales, Sydney, New South Wales</wicri:regionArea>
<wicri:noRegion>New South Wales</wicri:noRegion>
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<author><name sortKey="Sanchez Burs N, Juan Miguel" sort="Sanchez Burs N, Juan Miguel" uniqKey="Sanchez Burs N J" first="Juan Miguel" last="Sánchez Burs N">Juan Miguel Sánchez Burs N</name>
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<wicri:regionArea>Divisions of Rheumatology, Ophthalmology and Immunology, Valme University Hospital, Sevilla</wicri:regionArea>
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<author><name sortKey="Genovese, Mark C" sort="Genovese, Mark C" uniqKey="Genovese M" first="Mark C" last="Genovese">Mark C. Genovese</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
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<series><title level="j">Annals of the rheumatic diseases</title>
<idno type="eISSN">1468-2060</idno>
<imprint><date when="2017" type="published">2017</date>
</imprint>
</series>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Arthritis, Rheumatoid (complications)</term>
<term>Arthritis, Rheumatoid (drug therapy)</term>
<term>Azetidines (therapeutic use)</term>
<term>Double-Blind Method</term>
<term>Efficiency</term>
<term>Humans</term>
<term>Pain Measurement</term>
<term>Patient Reported Outcome Measures</term>
<term>Presenteeism</term>
<term>Protein Kinase Inhibitors (therapeutic use)</term>
<term>Quality of Life</term>
<term>Severity of Illness Index</term>
<term>Sulfonamides (therapeutic use)</term>
<term>Surveys and Questionnaires</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term>
<term>Azétidines (usage thérapeutique)</term>
<term>Enquêtes et questionnaires</term>
<term>Humains</term>
<term>Indice de gravité médicale</term>
<term>Inhibiteurs de protéines kinases (usage thérapeutique)</term>
<term>Jeune adulte</term>
<term>Mesure de la douleur</term>
<term>Mesures des résultats rapportés par les patients</term>
<term>Méthode en double aveugle</term>
<term>Polyarthrite rhumatoïde ()</term>
<term>Polyarthrite rhumatoïde (traitement médicamenteux)</term>
<term>Présentéisme</term>
<term>Qualité de vie</term>
<term>Rendement</term>
<term>Sulfonamides (usage thérapeutique)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Azetidines</term>
<term>Protein Kinase Inhibitors</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Arthritis, Rheumatoid</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Arthritis, Rheumatoid</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Polyarthrite rhumatoïde</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Azétidines</term>
<term>Inhibiteurs de protéines kinases</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Double-Blind Method</term>
<term>Efficiency</term>
<term>Humans</term>
<term>Pain Measurement</term>
<term>Patient Reported Outcome Measures</term>
<term>Presenteeism</term>
<term>Quality of Life</term>
<term>Severity of Illness Index</term>
<term>Surveys and Questionnaires</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Enquêtes et questionnaires</term>
<term>Humains</term>
<term>Indice de gravité médicale</term>
<term>Jeune adulte</term>
<term>Mesure de la douleur</term>
<term>Mesures des résultats rapportés par les patients</term>
<term>Méthode en double aveugle</term>
<term>Polyarthrite rhumatoïde</term>
<term>Présentéisme</term>
<term>Qualité de vie</term>
<term>Rendement</term>
</keywords>
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<front><div type="abstract" xml:lang="en">To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).</div>
</front>
</TEI>
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